Kornimate/medical-research-clean huggingface dataset:
the charm study-coordinating transitions from hospital for older adults with fractures

Conditions: Fracture; Frailty; Aging

Summary: background: fall-related injuries like fractures are on the rise among older adults in new brunswick. these injuries can lead to hospitalization and adverse health effects. moreover, transitions from acute care can be complicated and overwhelming, especially for patients and their families. researching patient navigators as a means of enhancing inpatient care, while also ensuring successful transitions in care for patients, may have positive impacts and help older adults successfully age in place. objective: this study seeks to investigate the effects of having support from patient navigators in helping older adults admitted to the orthopedic unit with a fracture. specifically, the objectives are to investigate whether there are differences between patients with patient navigators and those patients receiving standard of care, regarding: the length of stay in acute care; healthcare utilization post-discharge; patient and family experience and satisfaction with care; and, healthcare provider experiences working with patient navigators. methods: this study uses a mixed-method concurrent embedded design, in which the quantitative randomized control trial has an embedded qualitative component. potential benefits/risks: this study is considered low risk. potential benefits of this study include a better understanding of the impact of support from a patient navigator on inpatient care and patient transitions. this information will be used to inform the development of practical recommendations for policymakers and clinicians on how to enhance inpatient acute care and successful transitions for older adults.


Eligibility criteria:
inclusion criteria: patients 65 years of age and older admitted to the orthopedic unit at sjrh (ou) for a fracture - exclusion criteria: -

Keywords: patient navigation
evaluation of common bean baked snack consumption on blood lipids in overweight people with altered blood lipid levels

Conditions: Dyslipidemias

Summary: introduction: the mexican population consumes vegetables and snacks with the same frequency. besides, most of the snacks available on the market contain high fat, sodium and calorie, and low protein levels. regular consumption of these snacks and low physical activity could promote the development of noncommunicable diseases. common bean-based snacks are potential healthier alternatives to replace conventional snacks. hypothesis: the consumption of a common bean baked snack (phaseolus vulgaris l.) reduces blood lipid levels in overweight people with altered blood lipid levels. objectives: evaluate the effect of common bean baked snack consumption on blood lipid levels in overweight people with altered blood lipid levels. material and methods: randomized crossover clinical trial, 28 patients with altered blood lipid levels, 18-40 years old, snack supplementation for four weeks, clinical and laboratory determinations, such as total cholesterol, triglycerides, ldl, hdl, among others. * intervention phase: common bean baked snack intervention. * control phase b: no intervention.


Eligibility criteria:
inclusion criteria: * bmi between 25.0 and 29.9 kg/m2, * abnormal serum lipid levels: * total cholesterol: ≥200 mg/dl, * low-density lipoproteins: 100 to 190 mg/dl, * high-density lipoproteins: \<50 mg/dl in females and \<40 mg/dl in males, * triglycerides: 150 to 500 mg/dl. exclusion criteria: * pregnancy or lactation, * plans to lose or gain weight in the next three months, * modification of diet or physical activity in the last three months, * diagnosis of diabetes, cancer, hypertension, heart disease, gastrointestinal disorder, pancreatitis, kidney, liver or thyroid disease, * smoking or drug use, * sensitivity for bean consumption, * pharmacological treatment or consumption of non-prescription drugs, herbal or nutritional supplements known to modify serum lipid levels.

Keywords: functional food common bean snack
a study of avastin (bevacizumab) and transarterial chemoembolisation (tace) treatment in patients with liver cancer

Conditions: Liver Cancer

Summary: this single-arm, open-label study assessed the efficacy and safety of avastin (bevacizumab) treatment combined with transarterial chemoembolisation (tace) in patients with localized unresectable liver cancer. patients were treated with tace at 8 or 10 week intervals for 4 sessions (continuation depended on investigator's discretion). avastin 5 mg/kg intravenously was administered 24-48 hours prior to each tace session and every 2 weeks between the tace sessions until disease progression.


Eligibility criteria:
inclusion criteria: * adult patients, ≥ 18 years of age. * liver cancer, not suitable for resection. * at least 1 measurable lesion, and overall tumor lesions occupying \< 50% of liver volume * eastern cooperative oncology group (ecog) performance status 0-2. exclusion criteria: * patients receiving concurrent radiotherapy or immunotherapy. * patients who have received previous chemotherapy, biological agents, or radiotherapy. * prior transarterial chemoembolisation (tace) or transarterial embolisation (tae). * prior liver transplantation or liver resection. * current or recent (within 10 days of study start) use of full-dose anticoagulants for therapeutic purposes. * patients with high risk esophageal/gastric varices.
intraoperative dual-modality imaging in renal cell carcinoma

Conditions: Carcinoma, Renal Cell

Summary: intraoperative tumor localization and resection can be enhanced using intraoperative fluorescence imaging and radiodetection. girentuximab specifically recognizes carbonic anhydrase ix expressed on \> 95% of renal cell carcinoma (rcc). therefore indium-111-dota-girentuximab-irdye800cw is a perfect dual-labeled antibody for dual-modality image-guided surgery in rcc. the aim of this study is to assess the feasibility and safety of intraoperative dual-modality imaging with indium-111-dota-girentuximab-irdye800cw in renal cell carcinoma patients.

in oncologic surgery complete tumor resection is important for treatment outcome and patient survival. intraoperative tumor localization and resection can be enhanced using intraoperative imaging techniques (e.g. targeted radioguided or fluorescence guided surgery). a powerful synergy can be achieved by combining radiotracers (e.g. indium-111) and optical tracers (e.g. irdye 800cw) conjugated to an antibody against a tumor-associated antigen. girentuximab specifically recognizes carbonic anhydrase ix expressed on \> 95% of renal cell carcinoma (rcc). therefore indium-111-dota-girentuximab-irdye800cw is a perfect dual-labeled antibody for dual-modality image-guided surgery in rcc. the concept has been shown in preclinical studies with mice and the investigators will translate this to the clinic. eligible patients with renal cell carcinoma scheduled for (partial) nephrectomy will receive dual-labeled girentuximab 7 days before surgery. at day 4 or 5 a spect/ct of the abdomen will be obtained. surgery at day 7 will be extended with the use of a near-infrared fluorescence camera and a gamma probe. the aim of this study is to assess the feasibility and safety of intraoperative dual-modality imaging with indium-111-dota-girentuximab-irdye800cw in renal cell carcinoma.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of clear cell renal cell carcinoma planned for surgery, (partial) nephrectomy * performance status: karnofsky 70 % * being fit for surgery * minimum age 18 years * signed informed consent exclusion criteria: * a known subtype other than clear cell rcc * any medical condition present that in the opinion of the investigator will affect patients' clinical status. * administration of a radioisotope within 10 physical half lives prior to study enrollment * pregnancy and lactation
study evaluating the treatment of otx-tki for subjects with neovascular age-related macular degeneration

Conditions: Neovascular Age-Related Macular Degeneration

Summary: evaluate the safety, tolerability, and efficacy of otx-tki for intravitreal use in subjects with neovascular age-related macular degeneration

multicenter, double masked, randomized, parallel-group study to evaluate the safety, tolerability, and efficacy of otx-tki for intravitreal use in subjects with neovascular age-related macular degeneration

Eligibility criteria:
inclusion criteria: * have a diagnosis, within 3 years of screening, of previously treated subfoveal neovascularization (sfnv) secondary to namd with leakage involving the fovea, previously treated with documented evidence of an initially favorable clinical response to anti-vegf therapy (i.e. aflibercept, ranibizumab, brolucizumab, or bevacizumab). * the macular appearance on oct is considered to be free of excess intraretinal and/or subretinal fluid as judged by the investigator. * must have received at least 3 anti-vegf injections in the past year. * have received the most recent anti-vegf injection within the past 1-4 weeks prior to screening visit. * bcva etdrs score between 24 and 83 letters (\~20/25 to \~20/320 snellen equivalent) exclusion criteria: * have evidence of a scar, fibrosis or atrophy of \>50% of the total lesion in the study eye * have presence of a disease other than choroidal neovascular membrane (cnvm) due to amd in the study eye that could affect vision or safety assessments * have monocular vision (fellow eye snellen bcva is 20/200 or worse
ultrasound to verify lung-isolation during single-lung ventilation

Conditions: Thoracic Diseases

Summary: the purpose of the current study is to prospectively evaluate the usefulness of thoracic ultrasonography in demonstrating effective lung isolation during single-lung ventilation (slv) in the pediatric patient. the primary hypothesis is that ultrasonography will accurately verify lung separation during slv, as compared to fiberoptic bronchoscope (fob).


Eligibility criteria:
inclusion criteria: * requiring single lung ventilation for thoracic surgery exclusion criteria: * none
respiratory physiotherapy and neurorehabilitation in patients with post-covid19 sequelae.

Conditions: COVID-19 Pandemic

Summary: the objectives are to reduce dyspnoea, increase exertional capacity, increase vital capacity and respiratory muscle strength. vital capacity and respiratory muscle strength. in addition to increasing the sensibility of smell and taste, observing if there is a relationship between the decrease of these senses with the senses with appetite and whether appetite has normalised in post-sars-cov-2 patients. it is a randomised and blinded experimental study with a control group where the sample recruited will be 30 patients, with a range of of 30 patients, with an age range of 19-42 years, where they carried out an assessment of spirometry, modified borg dyspnoea scales and modified medical research council (mmrc), singapure (mmrc), singapore smell and taste questionnaire (sstq) and weekly smell and taste questionnaire. taste questionnaire.


Eligibility criteria:
inclusion criteria: * age range between 18 and 42 years. * patients with respiratory sequelae post covid-19. * patients with smell and taste sequelae post covid-19. exclusion criteria: * under 18 years old. * over 42 years old. * patients not diagnosed with covid-19 (pcr positive).

Keywords: coronavirus physiotherapies techniques physiotherapies specialty agnosia for taste breathing exercises
a clinical trial to evaluate the efficacy and safety of testosterone gel

Conditions: Adult Male Hypogonadism

Summary: this is a phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone concentrations \<300 ng/dl. the purpose of this study is to evaluate the safety and efficacy of testosterone gel (2%) delivered using an applicator.


Eligibility criteria:
inclusion criteria: 1. males between 18-75 years of age 2. two screening serum testosterone values less than 300 ng/dl 3. one or more symptoms of testosterone deficiency exclusion criteria: 1. previous use of the investigational product 2. use of any investigational product within 30 days prior to screening and during the study 3. bmi less than 18 kg/m\^2 or more than 35 kg/m\^2 4. prostatic mass(es) 5. generalized skin irritation or skin disease 6. lower urinary tract obstruction 7. myocardial infarction or cerebrovascular accident in the last 6 months 8. unstable angina or congestive heart failure 9. thromboembolic disorders 10. sleep apnea 11. hyperparathyroidism or uncontrolled diabetes 12. untreated moderate to severe depression 13. history of testicular, prostate, or breast cancer 14. hiv, hepatitis b, or hepatitis c positive 15. psa more or equal to 3 ng/ml 16. use of any medications that could be considered anabolic 17. use of estrogens, gonadotropin releasing hormone agonists/antagonists, antiandrogens, or human growth hormone 18. chronic use of any drug of abuse 19. involvement in a sport in which there is a screening for anabolic steroids 20. not willing to use adequate contraception during the study 21. partner is pregnant and/or breast feeding 22. partner has a history of breast, uterine or ovarian cancer
mesenchymal stem cells to treat type 2 diabetes

Conditions: Type 2 Diabetes; Mesenchymal Stem Cells

Summary: umbilical cord mesenchymal stem cells indicate the therapeutic effects and safety on type 2 diabetes by characteristics of secretion and immune immunomodulation.

umbilical cord mesenchymal stem cells can improve insulin resistance of the target tissues, reduce the islet progressive damage, ease or regenerate of the islet beta cells and improve hyperglycemic state of diabetes by secreting a variety of cytokines. it can induce damaged alpha cells differentiate into beta cells in the islet transformation to realize the islet beta cells in situ regeneration by improving microenvironment of islet beta cells. umbilical cord mesenchymal stem cells also have immunosuppressive effect, it can promote islet cell repair and regeneration by the inhibition of t cell mediated immune response to beta cells.

Eligibility criteria:
inclusion criteria: 1. 20 ≤ age ≤ 65 years; 2. duration of type 2 diabetes ≤20 years; 3. 24.0 kg/m2 ≤ bmi ≤40.0 kg/m2; 4. stable exogenous insulin dose between 0.5-1.0 u/kg/day with or without oral hypoglycemic agents (dipeptidyl peptidase-4 (dpp-4) inhibitor, glucagon like peptide 1 receptor (glp-1r) agonist and sodium-glucose co-transporter 2 (sglt-2) inhibitor excluded) for at least 3 months; 5. 7.0% ≤ hba1c ≤ 12.0%; 6. fasting c-peptide ≥ 1ng/ml; 7. willingness to participate in the trial. exclusion criteria: 1. patients with ketonuria, tumor, serum creatinine level more than 175μmol/l, myocardial infarction in the previous year, current angina or heart failure, more than one major vascular event, retinopathy requiring laser treatment, malignant hypertension, uncorrected endocrine disorder, occupations precluding insulin therapy; 2. severe concurrent illness limiting life expectancy, inadequate understanding of the study protocol, drug abuse, pregnant willing and allergic constitution.
short term effect of post surgical treatment of mirror therapy of phantom limb pain

Conditions: Phantom Limb Pain

Summary: the aim of the study is the measurement of the short term effect of post surgical mirror therapy concerning pain intensity and frequency of patients with upper or lower amputation in comparison to standard occupational or physical therapy. the hypothesis is that patients in the intervention group (mirror therapy) suffer significantly less from phantom limb pain and pain attacks within a follow-up period of 4-8 weeks.

aim: * measurement of the short term effect of post surgical/ post-operative mirror therapy concerning pain intensity of patients with upper or lower amputation in comparison to standard occupational/ physical therapy * hypothesis: patients in the intervention group (mirror therapy) suffer from significant less phantom limb pain and a lower pain frequency within a follow-up period of 4-8 weeks methods: * design: multicenter, prospective, randomized controlled trial * participants: 70, 35 per intervention and con-trol group * intervention group: treatment sessions of 60 minutes with mirror therapy over a period of 14 days starting directly post surgical (24-48 hours) * control group: receive treatment session of 60 minutes with the same treatment frequency over a period of 14 days * measurement tools: primary objectives * pain intensity (11 point nrs, phantom limb in-tensity) * pain frequency (amount of pain attacks) secondary objectives * diary * daily assessment of mirror and physical thera-py sessions * analysis: * in significant differences between the groups a covariance analysis will be performed * comparison of medians

Eligibility criteria:
inclusion criteria: * major amputation of lower and upper body * phantom pain, or pain attacks in combination with a treatment wish * age of 18 years * signed informed consent * linguistic and cognitive comprehension exclusion criteria: * bilateral amputation * major neurologic comorbidities (stroke, parkinson disease) * morbidities of the contralateral side with functional limitations * experience with long term standardised mirror therapy * internal comorbidities (pavk) * psychological comorbidities

Keywords: phantom limb pain mirror therapy amputees phantom limb occupational therapy
prostate cancer patients with biochemical recurrence

Conditions: Patients With Prostate Cancer

Summary: evaluation of detection rate of 18f-fluciclovine compared to current standard of care imaging techniques within 30 days of the standard of care imaging study and a 6 month phone follow-up

when bcr is present, detection of recurrence as well as the location, distribution and number of metastatic sites would determine the choice of subsequent management. in the search of malignancy in patients with bcr, standard of care tests include pelvic ct or mri (to look for recurrence and/or pelvic nodal metastases) and a planar bone scan to look for skeletal metastases. however, standard of care testing has a low diagnostic yield of only 11% of patients for visualizing sites of disease (5). thus, there is a clear need for better imaging approaches. 18f-fluciclovine is a synthetic amino acid pet tracer approved by the food and drug administration in june of 2016 for the detection of sites of recurrence in men with rising prostate-specific antigen levels after prior primary treatment of prostate cancer (6), based on its diagnostic performance (7,8). however, there is a gap in the literature regarding prospective studies evaluation of detection rate of 18f-fluciclovine compared to current standard of care imaging techniques. therefore, 18f-fluciclovine has already been approved by the fda and covered cms and insurance companies but is yet to be included in the nccn guidelines in the work up of pca patients with bcr.

Eligibility criteria:
inclusion criteria: 1. age \>18 and ≤89 2. history of prostate cancer which required surgical resection or radiation 3. documented biochemical recurrence defined as a positive psa any time after the initial diagnosis of prostate cancer which at that time required surgical resection or radiation and then had a negative result to a post treatment psa. 4. patient undergoing standard of care work up pelvic ct or mri, 99mtc-mdp bone scan, and f18 naf pet/ct. - exclusion criteria: 1. bcr with negative 99mtc-mdp bone scan but 18f-naf pet/ct was not able to be done. -
transcutaneous intercostal nerve stimulation in spinal cord injury

Conditions: Neuropathic Pain; SCI - Spinal Cord Injury

Summary: the purpose of this study is to determine the safety, feasibility, and effectiveness of electric stimulation of the nerves along the intercostal nerves on pain and spasticity in spinal cord injury patients.

neuromodulation techniques are safely used as a treatment for neuropathic pain in chronic sci. neuromodulation techniques have also been safely and successfully used to strengthen the abdomen in stroke patients.10 most similar to our tins protocol is transcutaneous tibial nerve stimulation (ttns), which has shown to mitigate the development of neurogenic bladder in acute sci.6 however, neuromodulation is rarely performed in acute sci, and, to our knowledge, neuromodulation has not been performed to prevent the development of chronic neuropathic pain. there has been little published regarding the effects of electric stimulation upon the trunk in acute sci as a prevention for chronic neuropathic pain and spasticity. gaps in the knowledge which we intend to fill are: 1. safety and feasibility of tins in acute sci during inpatient rehabilitation. 2. effectiveness of a 2-week tins protocol in acute sci based on changes between admission, discharge, and weekly numerical pain scores and spasticity questionnaire scores in those with tins compared to sham tins for 2-months. 3. analysis of neuropathic pain medication dosages in those with and without tins at admission, discharge, and 2 months post-discharge, and evaluation of morbidity at 2- months post-discharge

Eligibility criteria:
inclusion criteria: * acute tsci paraplegia within 4 weeks of injury (n=22) * 18-75 years old * neurologic levels t1-t10 * english speaking * admitted to tirr with pain medications * tins can elicit visible or palpable abdominal muscle contraction exclusion criteria: * subjects with pacemakers, defibrillators, insulin pumps, and similar devices * history of peripheral neuropathy * history of premorbid symptoms of peripheral neuropathy (numbness and/or tingling in the lower extremities, sharp/jabbing/burning pain in the lower extremities, sensitivity to touch, lack of coordination, lack of sensation, muscle weakness, etc.) * history of nervous system disorder (i.e. prior sci, stroke, brain injury, degenerative diseases such as parkinson's disease, etc.) * ventilator dependent respiration * inability to speak * non-english speakers * pregnancy * history of chronic pain * intolerant to electric stimulation * intolerant to the trial sessions
clinical evaluation of hemospray in hemostasis of active variceal bleeding

Conditions: Variceal Hemorrhage

Summary: the objective of this study is to assess the effectiveness of hemospray in achieving initial hemostasis and decreased rate of re-bleeding in patients of acute variceal bleeding.


Eligibility criteria:
inclusion criteria : * 18 years and older * bleeding esophageal and / or gastric varices exclusion criteria: * patient is: \< 18 years of age * unable to consent * contraindicated to undergo endoscopy, * already hospitalized for another illness * pregnant or lactating * patients with altered post-surgical anatomy of the stomach * previously placed intrahepatic portosystemic shunt * patient treated by other endoscopic or surgical modalities within 7 days prior to the intended application of hemospray